FDG an Myocardial Infarction: The PIAF Trial (PIAF)

November 30, 2021 updated by: Francesco Giammarile, International Atomic Energy Agency

International Multicenter Trial on the Prognostic Value of Arterial 18F-FDG PET Imaging in Patients With History of Myocardial Infarction

In order to define distinct and reliable arterial 18Fluorodeoxyglucose (FDG) thresholds identifying patients at risk for cardiovascular events, patients with a history of myocardial infarction will be included in this international multicenter trial. Non-enhanced whole-body FDG PET/CT will be performed in all patients and the arterial FDG uptake in the carotid arteries as well as the aorta will be quantified by calculating different uptake parameters. In addition, FDG uptake in hematopoietic tissues (spleen, bone marrow), visceral adipose tissue (VAT) and different brain regions (e. g. amygdala) will be measured.

Furthermore, specific blood biomarkers including genetic biomarkers, which are linked to atherosclerotic disease with predictive power for future cardiovascular events, will be analyzed in a subgroup of patients. In part 2 of the trial, a 4-year follow-up period will be analyzed with a focus on the prediction of cardiovascular events (acute coronary syndrome, non-fatal ischemic stroke, ischemic cardiac death, other causes of death, coronary/vascular revascularization, new-onset of angina, symptomatic peripheral arterial disease and heart failure).

The predictive value of the arterial, hematopoietic and cerebral FDG uptake parameters as well as of the specific blood and genetic biomarkers will be determined.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

From a clinical perspective, atherosclerosis leading to arterial plaque rupture is one of the most important causes of death that still misses a personalized, reliable and quantitative assessment of risk. This is particularly true for patients who suffered from a non-fatal coronary syndrome, were recent studies described severe CVD event rates of up to 5 % per year despite the use of aggressive secondary prevention strategies.

While in previous clinical interventional trials inflammatory atherosclerotic activity was mainly determined by the surrogate marker high-sensitivity C-reactive protein, other studies have shown superiority of FDG PET/CT in the stratification of patients in high versus low risk groups, where risk in the highest (vs. lowest) TBR tertile was approximately 3-fold greater compared with what has been historically observed for the inflammatory blood biomarker, hsCRP. It is, thus, expected that imaging (vs. blood) biomarkers provide additional prognostic information that is more relevant to the artery wall per se, whereas currently used blood biomarkers carry information from vascular as well as nonvascular sources.

The current research aims at identifying distinct and reliable FDG PET threshold values, which specify the individual risk of a distinct patient. For this purpose, a well-designed and well-powered multicenter trial is needed.

Fundamentally, the research project aims at evaluating the prognostic value of arterial FDG PET/CT imaging of individuals with known cardiovascular disease (CVD). Specifically, we will:

  • Test the hypothesis that the baseline measures of arterial inflammation (as assessed by FDG PET/CT) independently predict the risk of CVD events (as coronary death, myocardial infarction, coronary insufficiency, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, revascularization, or heart failure) in a large cohort of individuals with prior MI.
  • Evaluate the incremental prognostic value of arterial inflammation (PET) over circulating blood biomarkers
  • Evaluate the prognostic value of inflammation data derived from various arterial locations (e.g. aorta, carotids, or other locations) for their ability to predict severe cardiovascular events
  • Identify cut-off values that indicate higher risk
  • Evaluate the predicted value of specific brain uptake, hematopoietic tissue (spleen, bone marrow) and visceral adipose tissue on emerging CV events. Evaluate the added value of combining those uptake values with arterial uptake
  • Evaluate the different established arterial FDG uptake parameters with regards to standardization and scanner type/variability
  • Apply deep-learning algorithms for detection of organ/tissue interactions and CV event hypothesis generation
  • Evaluate a subset of patients for inter-observer variability
  • Evaluate the detection rate of incidental PET/CT findings in the study cohort (suspected malignancies, other diseases)
  • Suggest novel diagnostic algorithms and clinical protocols accordingly
  • Evaluate the prognostic value of additionally derived genetic markers.
  • Specifically, we propose that patients with higher GRS have increased FDG PET/CT based inflammatory atherosclerotic activity and are prone to more MACE

Study Type

Observational

Enrollment (Anticipated)

2041

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Massachusetts General Hospital, Havard Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Patients 18-80 years of age
  • Patients with documented myocardial infarction > 90 days before study inclusion
  • Clinically stable at the time of screening and able to tolerate the study procedure

Description

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Patients 18-80 years of age
  • Patients with documented myocardial infarction > 90 days before study inclusion
  • Clinically stable at the time of screening and able to tolerate the study procedure
  • Female patients must not be pregnant at the time of FDG PET/CT imaging
  • Patients included in other clinical trials could be included, provided this complies with specific local and research center requirements
  • If after 6 months of patient recruitment it is foreseeable that the target number of patients will not be reached, patients who undergo FDG PET/CT imaging for cancer screening or surveillance can be included, provided that they have no evidence of an active malignancy on the scan or other exclusion criteria as listed below at study entry, including recent radio- and / or chemotherapy (≥ 12 months before the FDG PET/CT)

Exclusion Criteria:

  • Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema)
  • Extra-cardiac illness that is expected to limit survival to less than 4-5 years; e. g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or severe hepatic dysfunction, severe renal disease, active cancer
  • Patients with chronic use of anti-inflammatory medication (except NSAIDs and inhaled corticosteroids)
  • Patients with Diabetes Type I
  • Insulin-dependent or uncontrolled Diabetes Type II (as HbA1C>7.5)
  • Withdrawal of Informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular events
Time Frame: 4 to 5 years follow-up period
Cardiovascular events considered will be: coronary death, myocardial infarction, coronary insufficiency/acute coronary syndrome, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, revascularization, or heart failure
4 to 5 years follow-up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other cardiovascular events
Time Frame: 4 to 5 years follow-up period
coronary/vascular revascularization, new-onset of angina, symptomatic peripheral arterial disease and heart failure
4 to 5 years follow-up period
All-causes of death
Time Frame: 4 to 5 years follow-up period
All-causes of death
4 to 5 years follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Atomic Energy Agency

Investigators

  • Study Director: Francesco Giammarile, MD, PhD, International Atomic Energy Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRP13048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on History of Myocardial Infarction

Clinical Trials on 18F-FDG PET/CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe